Study of Knee Replacements for Patellofemoral Osteoarthritis (PFA/TKR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Aarhus
Sponsor:
Collaborators:
Stryker Nordic
DePuy Orthopaedics
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01326156
First received: May 19, 2009
Last updated: August 4, 2014
Last verified: May 2014
  Purpose

This is a randomized comparison of PFA and TKR in treatment of isolated patellofemoral osteoarthritis.


Condition Intervention Phase
Osteoarthritis, Knee
Device: Knee arthroplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patellofemoral Arthroplasty (PFA) Versus Total Knee Replacement (TKR) for Isolated Patellofemoral Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Patient-reported outcomes (disease-specific and generic QoL instruments) [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    The physical functioning score of the Short Form (36) Health Survey is the primary outcome measure of the study. Disease-specific patient-reported outcomes (Oxford Knee Score, KOOS and Kujala) and a second generic quality of life measure (EQ5D).


Secondary Outcome Measures:
  • Implant survival, clinician assessment and cost. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    Secondary outcome measures relate to implant survival, clinician assessment and cost. Implant survival will be assessed by 5- and 10-year implant survival rates and by analyzing causes for revision surgery. Clinician assessment includes Knee Society Score (stability, range of movement, effusion, tenderness etc.). Assessments of immediate and long-term costs are based on patient diaries, sick leave, use of medical services and drug prescriptions.


Estimated Enrollment: 100
Study Start Date: June 2007
Estimated Study Completion Date: January 2025
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avon patellofemoral replacement
Knee arthroplasty with insertion of patellofemoral joint replacement.
Device: Knee arthroplasty
Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.
Other Names:
  • PFA: Avon Patellofemoal arthroplasty (Stryker)
  • TKR: PFC Sigma CR arthroplasty (DePuy)
Active Comparator: PFC Sigma CR total knee replacement
Knee arthroplasty with total (tricompartmental) knee replacement.
Device: Knee arthroplasty
Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.
Other Names:
  • PFA: Avon Patellofemoal arthroplasty (Stryker)
  • TKR: PFC Sigma CR arthroplasty (DePuy)

Detailed Description:

Isolated patellofemoral osteoarthritis can be a disabling condition of the knee necessitating knee arthroplasty. It is debated whether total knee replacement or isolated patellofemoral replacement is the better treatment option. This randomized trial attempts to give a qualified answer to the debate by comparing clinical outcome (range of movement, stability, effusion, patellofemoral tracking, tenderness, stair climbing), patient self assessment scores (EQ-5D, Oxford Knee Score, KOOS, SF-36, AKS), complications (infections, revisions), longevity (survival analysis) and cost (direct and indirect) for the two implant types.

The Avon patellofemoral implant has been chosen, as this is the patellofemoral implant with the best documentation. The PFC Sigma CR total knee implant has been chosen as it a current standard implant and market leader.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Isolated PF-OA

Exclusion Criteria:

  • Medial or lateral OA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326156

Contacts
Contact: Anders Odgaard, FRCS, DMSc +45 8949 7575 ao@knee.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark
Principal Investigator: Anders Odgaard, FRCS, DMSc         
Sponsors and Collaborators
University of Aarhus
Stryker Nordic
DePuy Orthopaedics
Investigators
Principal Investigator: Anders Odgaard, FRCS, DMSc Dept. of Orthopaedics, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01326156     History of Changes
Other Study ID Numbers: 56789
Study First Received: May 19, 2009
Last Updated: August 4, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Osteoarthritis
Knee
Knee cap
Patella
Patellofemoral

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 26, 2014